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Glossary:TAG-00251-Spo-ezu

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Glossary > Sponsor safety reporting

Sponsor safety reporting
Tag-ID TAG-00251-Spo-ezu
English Sponsor reporting to authority / Sponsor reporting to competent authority / Sponsor reporting to IRB / Sponsor reporting to ethics committee
French Déclaration du promoteur à l'autorité / Déclaration du promoteur à l'autorité compétente / Déclaration du promoteur au CEI / Déclaration du promoteur au comité d'éthique
German Meldung des Sponsors an die Behörde / Meldung des Sponsors an die zuständige Behörde / Meldung des Sponsors an die Ethikkommission

References

 ScopeDocument partLanguageDocument
AUT MPG – Medizinproduktegesetz 26-May-2022 § 22MD§ 22DEAUT MPG – Medizinproduktegesetz 26-May-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64MD§ 64DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3MDArticle 80 Paragraph 3ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42HMArticle 42ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43HMArticle 43ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53GR1123-53FRFRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025
FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5.HM5.FRFRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025
GBR Directive 2001/20/EC 04-Apr-2001 Article 17HMArticle 17ENGBR Directive 2001/20/EC 04-Apr-2001
GBR Directive 93/42/EEC 11-Oct-2007 Annex XMDAnnex XENGBR Directive 93/42/EEC 11-Oct-2007
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 33HMArticle 33ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35HMArticle 35ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f)GIII. Annex 1

3.13.2

(a) - (b) ; (d) - (f)
ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c)GIII. Annex 1

3.13.2

(c)
ENICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b)HM§ 312.32 (b)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c)HM§ 312.32 (c)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d)HM§ 312.32 (d)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1)MD§ 812.150 (b) (1)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) - (3)MD§ 812.150 (b) (1) - (3)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (5)MD§ 812.150 (b) (5)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002MD§ 812.150 (b) (7)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (8)MD§ 812.150 (b) (8)ENUSA 21 CFR Part 812 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - SponsorHM7.2 - SponsorENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995